FWIW, I thought PFS was a good endpoint given the trial design with crossover. I agree with the rationale for using a crossover option, which is humane. That being said, it is a reminder that having a SPA from the FDA is always a good thing for a registrational trial. I am also invested in IMUC and am glad they got a SPA for their trial.
The most likely path to approval I see for DCVAX-L, assuming the assumptions about confounding are true, is primarily to have a interim approval, and requiring either follow-up, or another phase III study without crossover. I also think it is possible that the current protocol could be modified again, with an addendum removing the crossover option, and having a central body to assess progression.
All just speculation of course, but based on the statements from LL, and Bosch, it is at least plausible.
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